So you will remember the fish oil pill stories of last year. For the new kids: pill company Equazen and Durham Council said they were doing a trial on them with their GCSE year, but it wasn’t really a proper trial, for example there was no control group, and they had lots of similarly dodgy “trials” dotted about, which were being pimped successfully to the media as “positive”. When asked, Durham refused to release the detailed information you would expect from a proper piece of research. Even now, for all this pretending, there still has never been a single controlled trial, even a cheap one, of omega-3 fish oil supplements in normal children. Ridiculously.

It’s back to school time. The fish oil adverts are everywhere. But what were the GCSE results in Durham, for the GCSE cohort who took Equazen’s magic pills, this “trial”, repeatedly vaunted in every national newspaper (including this one), Channel 4 news, and more? 3,000 children signed up for their trial, swallowing six big ol’ capsules every day bless them, and there were only 5,000 GCSE candidates in total, so they got well over half the county (great recruiting).

This was an area of failing schools, remember, receiving a huge amount of extra effort and input of all forms. The preceding year, with no fish oil, the results – the number of kids getting 5 GCSE grades A* to C – had improved by 5.5%. And now? After the fish oil intervention? Well. This rate of improvement seems to have deteriorated spectacularly. I chased the results myself through Durham press office: this year there was only a 3.5% improvement. And this is against a backdrop of a 2% increase in GCSE scores nationally anyway. 1.5% over, in an area which was rapidly improving before, and which was receiving huge amounts of extra resourcesand input. You live by anecdata, you die by anecdata: you could argue this“trial” had a negative result.

In fact, did the fish oils retard the progress of the children in the year? It’s a possibility we must always be alive to, if we really are to believe that a pill can have an impact on a complex social issue like school performance. Income inequality, underpaid teachers, poor facilities, low morale, and inadequate recruitment would be my preferred explanations for poor education outcomes, but if you’re made happy by the idea that pills
can fix the problem then be my guest.

You might think it’s too early to expect results. Am I being mean? Impatient? Too demanding? Apparently not. Because wondrous, amazing, buy-more-now positive results of even more trials of fish oils have suddenly started appearing out of nowhere all over the media. Toft Hill School in – wait – Durham for example, has been gushingly written up in the Evening Standard, with a picture of the smiling headmaster holding a nice big box of Equazen brand fish oil. Even the Mirror gave it a nice page. This stuff costs 50 pence per child per day (and Durham only spends 70 pence on school meals).

You will remember, at the time, I suggested that this so-called trial in GCSE candidates was meaningless, since there was no control group taking placebo tablets. Getting the TV cameras in, raising expectations, and showering lots of extra attention, as Durham did, is bound to elicit a massive placebo benefit.

You may also remember how, in Durham, it was argued that a placebo control group would be “unethical”, since that would deprive some children of the benefit. This was absurd: we do not know if there is a benefit, that’s why we needed a proper trial, not these publicity shams.

But there is a genuine ethical issue at stake now: nonsense research – and this was probably the single most widely covered trial in the media for the whole of 2006 – undermines the credibility of trial research in general, and makes it more difficult to recruit into trials. It propagates cynicism about research, and encourages people to believe that trials are only done as a sham marketing exercise.

And here is the key ethical issue for today. People consent to being in a trial on the grounds that they will be contributing to the sum total of human knowledge, not to a marketing exercise. They give over their bodies – and their childrens’ bodies – as testing grounds for new pills, on those moral terms. If the results of this “trial” of fish oil pills are not published, in full: then it will be a grotesque betrayal of the faith put in the researchers by the parents and children of Durham.

We enjoyed the blanket media coverage of 2006. It was a meaningless “trial” at the best of times, but now you must give us the results. Especially when the newspapers have already managed to report the apparently positive findings of other “trials” – appearing out of nowhere – which gave you the outcome you wanted.

Meanwhile:

You can remind yourself exactly how Durham and Equazen marketed this “trial” – before they knew what the results would be – here.

I’ll jog your memory.

The Press Association call it a trial:

“The countywide trial at 36 schools will continue until the pupils finish their exams next summer. The first test of the supplement’s effectiveness will be when they sit their mock GCSEs in December.”

The Daily Mail call it a trial and talk about the results (next to a nice big glossy colour photograph of a box of Eye-Q brand omega-3 supplements, page 4 6/9/06).

“The trial will continue until their GCSE examinations next June – which will need £1 million worth of supplements supplied free. The company hopes the results of the project will then spark orders all over the country.” Quotes Ford talking about measuring the results, and Portwood calling it a trial too:

Mr Ford added: “We will be able to track pupil’s progress and measure whether their attainments are better than their predicted scores.” Dr Madeleine Portwood, senior educational psychologist at Durham county council, who has led much of the previous research into fish oils added: “The scale of this new trial is extraordinary. “Previous trials have shown remarkable results and I am confident that we will see marked benefits in this one as well.”

They also feature Portwood spouting: “and if we can improve the connections in the cortex then the limbic system is dampened down so the children are less excitable.” “It sounds complicated…” says the narrator.

“The County-wide trial will continue until the pupils complete their GCSE examinations next June, and the first test of the supplement’s effectiveness will be when they sit their mock exams this December.”

“The trial has won the backing of Durham County Councillors, who are committed to making a difference to children’s outcomes and improving their life chances.”

“All Year 11 pupils at Durham County Council’s 36 comprehensive schools are to be offered omega-3 fish oil supplements to see whether the proven benefits it has already brought children and young people in earlier trials can boost exam performances too.”

Fish Oil Initiative Could Boost Gcse Pass Rate

County recruits 5,000 Year 11 pupils for unique study

Education chiefs in County Durham are to mount a unique back-to-school initiative today which they believe could result in record GCSE pass levels next summer.

All Year 11 pupils at Durham County Council’s 36 comprehensive schools are to be offered omega-3 fish oil supplements to see whether the proven benefits it has already brought children and young people in earlier trials can boost exam performances too.

“We are able to track pupils’ progress and we can measure whether their attainments are better than their predicted scores,” said Mr Ford.

oh and at the bottom it says “eye q is commercially available through retailers such as Boots and Superdrug. For more information 0870 241 5621 or go to www.equazen.com“

And Equazen’s press release describes measuring the results, and calls it a trial

“The County-wide strategy will continue until the pupils complete their GCSE examinations next June, and the first test of the supplement’s effectiveness will be when they sit their mock exams this December. We are able to track pupils’ progress and we can measure whether their attainments are better than their predicted scores,” said Mr Ford.

“You will be invited to send a reporter and/or photographer to a media launch of the trial at a County Durham school on the morning of September 6 where key players in the initiative, including pupils, will be available for interview.”

In Conclusion

I win.

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29 Responses

doris said,

Chris said,

While I don’t dismiss the idea that fish oils may improve children’s learning ability, I would think that it would have to be administered on a long term basis from birth rather than just for a few months during exam year.
Also, I don’t know about relative prices in UK but here in New Zealand the Equizin brand is very expensive compared to many other fish oil products and probably not really any different

doris said,

I commented on the use of fish oils in a previous discussion.This article raises a number of queries:
firstly,what is the relationship between Equazen and Durham Council?
Secondly,if I understood yesterday’s article on the Ingelfinger rule and Mr Ward’s objections to it,this fish oil reporting would seem to substantiate Ben’s concerns.
I am convinced that income inequality and poor resources are the root cause of the elatively small improvement in the GCSe results of the Durham children.(Or a nocebo effect?)
No amount of gimmicky publicity and splash reorting wil disguise the fact that nearly 30 years of privatisation and market-based policies,have led to a massive,and growing,disparity between the haves and have-nots.
Finally,the widespread use of fish oils is questionable at a time when fish stocks are collapsing.

Dr T. fortunei said,

thanks Doris, for raising the fish stocks question. It has concerned me for ages that the effect of the fish oil trend will result in more ships out there hoovering up anything remotely fishy…. for food? no, pills.

Why the focus on fish anyway? sure they are concentrated, but there are other sources. Reading the press you would be hard pressed to come to any conclusion other than that the population in general who mostly don’t (and crucially, have probably never) eaten oily fish twice a week, or spoons of linseed oil are horribly malnouriched in some way. It doesn’t add up.

gadgeezer said,

Doris, Dr T forunei, never fear, it looks as if one of Equazen’s most vocal patrons, Patrick Holford of the Food for the Brain Foundation is trying to persuade us that we need to take seal oil supplements.

Sure, Holford’s recommending Equazen and some salmon oil thing for now, but give him a little more time with Biocare and it will be

Club a seal, save your kid’s brain cells.

On the anecdata front, weren’t various of those primary school tests that were publicised by Sir Trevor filled with smiling children who had changed their behaviour within days of taking fish oils. Mrs G’s explanation for why children don’t run round after taking fish oil, it makes you burp them back. Like those people a few years back who took garlic capsules with mint so used to burp a disgusting taste concoction.

doris said,

I’ve just read about Holford and his contradictory statements on DPA on Quackwatch.
The man is unbelievable but,sadly,all too plausible to many credulous punters.
If he has links with Equazen,did he take an active role in the Durham fish oil project?
If so,on what basis?
I think the RSPCA might take an interest if he keeps on with the seal oil nonsense.

UncleJoe said,

By the way, I’ve noticed the name “Jane Roscoe”, described as ‘study leader’, in a lot of fish-oil ads – does anyone know who the hell Ms Roscoe actually is? As far as I can tell from some intensive googling, she’s some sort of functionary on Bolton Council but I wouldn’t mind knowing exactly what the post of ‘study leader’ involved here.

It’s naive to think that because a natural nutrient is not recognized as good for any health problem by pubmed and medline it is not good.
You must remember that these companies are representatives of the medicine manufacturers and that no natural cure (not patentable) will be acknowledged unless scientifically proved by someone else. No medicine company is interested in any natural cure for anything since it cannot be patented and they will surely sell you an artificially patented medicine with lots of side effects rather than acknowledge the benefits of a natural cure.
See CMO for arthritis for example.

to which i replied, like the over helpful correspondent that i am…

What about the multimillion pound pill company Equazen, with a massive PR operation promoting its pills, and owned by Gallenica, one of the top 15 over the counter pill corporations in the UK?

“Galenica is a diversified Group active throughout the healthcare market which, among other things, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. The Galenica Group enjoys a leading position in all its areas of activity – pharmaceutical manufacturing, prewholesaling, distribution, healthcare information and retailing. A large part of the Group’s income is generated by international operations.”

So, “No medicine company is interested in any natural cure for anything”

It’s just tragic, it’s a diversion and the money maybe diverted from things that count a complete waste. I don’t want to generalise, but education here in the UK seems to attract schemes that aren’t evidence based (brain gym, faith based schemes, etc. etc.) There seems to be an attitude of ‘well if it gives the kids some extra attention it must be OK’ or ‘they use it in American schools’ or ‘I don’t think it will do any harm’. It’s a kind of good natured appeasement. What an example to set for the kids. No doubt science teachers and many teachers of other subjects find such situations maddening.

statement said,

Good work as ever.
I wonder if any children have thought, ‘I don’t need to revise, I’m on the fishy pills’. Has anyone asked the children what they thought the pills would do for them? Obviously it is a bad message to give to children – take this pill and you will do OK!
That headmaster with the box of pills: it’s a sort of smile but is there a look of embarrassment playing on his face as well?

And for the deluded public who buy into the fiction of the ‘natural, safe and necessary’ supplement market, just remember – they’re a business. Out for profit. Exploiting their market of worried well free from any objective scrutiny by any Govt health body. Just imagine if Roche/ Abbott/ Janssen tried the same tactics….

And for those who continue to Ben forgot to add to the Galenica press release:

“Equazen products generated a turnover of about CHF 20 million in 2005″

bk said,

Absolutely infuriating. This is just cynical peddling of pills instead of the less sexy, less trendy message of a good balanced diet and plenty of exercise, as well as, in this case, some hardworking and interested teachers. This example is particularly annoying since consumption of actual, you know, fish, is way down in this country, especially amongst school age children, which deprives people of a load of benefits they don’t get from expensive pills.

A massive waste of money – the quacks are rubbing their hands while money that could be invested directly into the education system, or into school meals, is thrown at bottles of completely unproven pills.

“Improvement is improvement. And you can’t predict that the 2007 exam results were always going to be better than 2006 just because the 2006 exam results were better than 2005.”

True enough, but by looking at the Key Stage whatever results you will get an idea of how much better _this_ cohort is likely to be compared to the year before – and then estimate what sort of magnitude improvement would be consistent with the known improvovement of this cohort.

JoanCrawford said,

“You’re completely right – what we need is proper scientific research to find out once and for all whether parents should consider Omega 3 a worthwhile supplement. I’m in touch with Dr Alex Richardson on the subject (she also pointed me in the direction of Ben’s site!) and it seems that up until now no one is willing to take on funding for this research.
In the meantime we are left with just anecdotal evidence and the Oxford-Durham report – do we keep quiet about the potential help omega 3 can offer children with learning difficulties and hope that sometime soon the proper research will happen ?
Best wishes
Cathy Court
Netmums”

It sounds like she is actually trying to do the right thing, in fairness. My main misgiving here is that having agreed that there isn’t any proof for the efficacy of the pills, all the Equazen stuff is still posted up for any number of mums to read.

And I guess that Equazen pay for the advertorial, and that Cathy and her colleagues do have a living to make.

None of which alters the fact that the fish oil pedlars are still fibbing. A lot.

emilypk said,

Of couse she is trying to do the right thing but the question of who should pay for the research is astoundingly niave. The company profiting from the unproven product should. So long as the uniformed consumer gives the benefit of the doubt research is simply an unecessary risk and expense. The thing is, every effective drug has multiple effects and side effects. If it does anything at all it may not be something good.

The journal is a perfectly respectable PubMed-listed one, and Puri has published there a lot. And “in press” is usually taken in science to mean: “accepted in final form and waiting to appear”.

BUT…. two years later no such paper has ever appeared, leaving various alternatives (withdrawn, rejected, still in the works). But it seems crystal clear that the results of this trial have never appeared in a peer-reviewed scientific paper.

BSM said,

bf said,

I recently saw a consultant neurologist at the National Hospital for Neurology and Neurosurgery in London about my persistent memory problems among other things. In addition to booking me in for some tests, he suggested that in the meantime I try Omega 3 (fish oil) and Evening Primrose oil.

I queried this (on the grounds of lack of research evidence) and we had a brief but intelligent discussion. He said that despite the lack of research data he thought they would at least do no harm, and the anecdotal evidence suggests that they might help. He said it would be hard to test their efficacy on e.g. demented patients, and they may have no beneficial effect on normal people, but they might help in-between cases like me with mild memory problems.

I reckon he suspected the effect might be largely placebo, as do I, but that is not a reason not to try it. (In addition to testing for identifiable causes.)

Better nutrition (including Omega 3 fatty acids amongst other things) appears, from an unprofessional eye reading a 1990’s study that took place in Aylesury Prison, to make a difference to antisocial behaviour also.

“…The double-blind, placebo-controlled, randomised trial, published in the British Journal of Psychiatry (2002) Vol. 181, pages 22-28 attracted an extremely favourable response from the academic community for the high standard of the methodology, as well as considerable press interest…”